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California Cracks Down On Genetic Testing
Posted by
kdawson
on Tue Jun 17, 2008 04:43 PM
from the first-salvo-in-a-long-campaign dept.
from the first-salvo-in-a-long-campaign dept.
genie-out-of-the-bottle writes "California's Department of Public Health has sent cease-and-desist notices to 13 companies that market genetic testing directly to consumers. (We discussed these services when they launched.) Allegedly, under state law, California residents must submit a doctor's order to have a genetic test run. It will be interesting to see if the government will actually succeed in putting the genetic genie back in the bottle, given that all you need for testing is a few drops of saliva. The effort closely resembles US government attempts to block export of strong encryption product back in '90s." A Wired editor has up an opinion piece arguing that his DNA is his business and none of the government's.
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100,000 Californians To Be Gene Sequenced 158 comments
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You don't own your DNA (Score:5, Funny)
Sorry Tom, but the information isn't yours. Much of "your" DNA is patented. If you don't intend to pay the licensing fees, then you should expect to receive a C&D shortly.
Re:You don't own your DNA (Score:5, Funny)
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Re:You don't own your DNA (Score:5, Funny)
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Re:You don't own your DNA (Score:5, Informative)
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Re:You don't own your DNA (Score:5, Informative)
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Re:You don't own your DNA (Score:5, Informative)
What was being patented was a purified sequence of DNA for use in a diagnostic test. It's not the DNA itself--there's 10 million years of prior art for that--but the use of a particular sequence of DNA for diagnostics.
The total human genome is over 3 billion base pairs. Companies were racing to figure out which small sequences (100 or so pairs) would be useful in diagnostics and possibly in therapy. The use of DNA for that purpose was completely new at the time.
For example, check out this DNA patent application [uspto.gov]. The application refers to a specific DNA sequence, but the patent itself is for the use of that particular sequence for a specific kind of therapy.
It's still perfectly legal to reproduce, sell your DNA in a bottle, and so forth. The only thing the patent covers is the use of one very short sequence in a particular kind of therapy.
It might still be bad policy, but it's not as if you don't own your DNA.
Parent
Re:You don't own your DNA -the GIAA (Score:3, Funny)
thanks dude!
Re:You don't own your DNA (Score:5, Insightful)
A lot of commercial genetic testing is scientifically worthless, even harmful if they give you bad information about what your genetics actually means for you or your children. There needs to be some kind of regulation (regarding claims they can make, information supplied to customers, actual evidence for the disease-test relationship they claim etc), but at the moment the public health people can't agree on what form that regulation should take, so there might be a lot of this 21st century snake-oil around for a long time.
I don't know anything about California, but it could be that the government is trying to protect people from possible harms of bad and unnecessary testing.
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All our base pair are belong to us? (Score:5, Informative)
The interesting thing is that this technology is evolving so rapidly that the type of testing California is cracking down on is going to look quaintly prehistoric in just a few years. Roche is expected to launch a commercial high resolution version of its 'sequence capture' platform in the next few months which, combined with a 'next generation' sequencing system (like Roche's own 454 machine), should allow complete human 'exomes' (all the well-defined mature gene transcript sequences in a sample) to be completely sequenced for a few thousand dollars. But this, of course, is just the first step. One or more of the future sequencing technologies currently in development is likely to bring entire human genome sequences into this price range:
http://genomics.xprize.org/ [xprize.org]
with the eventual Holy Grail of a '$1000 genome' now seeming pretty much inevitable. But some of the teams competing for the genomics X-prize don't intend to stop there - e.g., Reveo claims to be aiming to produce a practical nanotechnology-based instrument 'in 5-10 years that will cost less than $1000 and sequence the whole genome and simultaneously the epigenome (methylation code) nearly error free in a minute for pennies per genome.'
So what happens if it's possible to buy an extreme throughput sequencer for the price of a laptop, and decode a genome as effortlessly as cracking CSS on a DVD? Is this particular genie really likely to stay in the bottle? And is it in any case defensible that knowledge of an individual's genome should ('for his own good') remain the province of an exclusive medical priesthood, rather than of the individual himself?
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Re:You don't own your DNA (Score:4, Informative)
The US Government Accountability Office compiled a report of genetic testing that is available here [gao.gov], although it's only a smallish snapshot of the current situation.
Both the positive and negative implications for widespread genetic testing are favourite subjects of Ron Zimmern and Muin Khoury, and if you're interested you'll find a lot of discussion of genetic test regulation by searching for them. There's a newspaper report of a study by Khoury here [guardian.co.uk], but annoyingly I can't find the original work.
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Doctors contribute to government corruption. (Score:4, Insightful)
Re: (Score:3, Insightful)
While there are some half-decent arguments (reactionist people taking tests then making up their own "treatment" plan for their 1% chance of developing condition X), I agree this is for doctors.
These kind of rubber stamp things (since I assume most doctors would just say "yes" to simplify their lives) just raise health care costs. By requiring this signature you take up the doctor's time and it's harder for you to compare and get things done.
This seems like regulation for the sake of regulation to me.
Re:Doctors contribute to government corruption. (Score:5, Insightful)
Likewise if a family member has such symptoms or his side of the family has these traits, genetic testing is disallowed unless the person actually agrees to it. I.e. a wife wants to know if her husband has Huntington's, she cannot force him to take a test or bring a sample to a physician and ask for it to be tested. Even if she only wants the information for future conception, the doctor won't allow it.
What's to keep someone - anyone - your wife, boss, insurer, whoever, from taking that toothpick you used after lunch and sending it in to one of these companies?
I think the law is intended to protect YOU from others, not from yourself. If you actually have some problem then you can go to a physician and have total confidence that the only person who will know the result is you and him. Hell, you can even withhold it from him if you wish. As it is now a person can send in ANYONE'S DNA and get their result.
I'd rather go to a doctor than leave that second option as a possibility. That's the option that leads down the road to real Gattaca-style shit. It's a future I'd rather NOT live in.
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Re:Doctors contribute to government corruption. (Score:5, Funny)
Please, that will never happen. You're just being paranoid. And of course, such irrational paranoia is exactly the type of behavior I would expect, given that you have a repeating ATTCAGGGATTAG sequence on your chromosome 3, which results in a 500% increase in the risk of developing paranoid schizophrenia.
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Re: (Score:3, Insightful)
While this _would_ increase the number of office visits, it's likely that it would not generate a great deal of revenue, since it would likely be coded at the lowest level.
I know a number of primary care physicians, and this just isn't the type of visit that they would try to encourage. Furthermore, most physicians I know (IMHO all responsible ones) would discourage unwarranted genetic testing, as well as any other type of medica
Re: (Score:3, Interesting)
Re:Doctors contribute to government corruption. (Score:4, Insightful)
It's a case of balancing the risks against the rewards. Sure you might find it interesting, but a lot of people will get tests which are often meaningless medically and which they will base lifestyle or health choices on.
I'm not sure on which side of the argument I'm on at the moment, but I'm very nervous about the prospect of people selling tests for disease genes without any requirement for evidence of the disease-gene interaction, and for the correct information for the implications to be supplied to customers.
Would you like to know your SORL1 genotype? What if I told you it was possibly liked to Alzheimer's disease? What if I told you it was definitely liked to young onset Alzheimer's disease, but I was lying? Would you like your wife's genotype? How would you interpret the information? I understand the intellectual curiosity and freedom points of view but this can do harm as well as good.
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Maybe it's actually a good thing (Score:5, Insightful)
Re:Maybe it's actually a good thing (Score:5, Insightful)
Perhaps what should be banned is accepting DNA samples indirectly.
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I do support this, in some ways. (Score:5, Interesting)
What kind of crap is this? So, basically, I could collect the saliva (Don't ask how) of various people I know, send it in, and have ready access to their genetic information? HIPAA should be all over this like white on rice. With no actual strong safeguards on this stuff anyone could theoretically easily gain access to your genetic profile.
A better solution is to be able to do it freely, you actually have to show up at the lab and be able to certify you are who you say you are. Perfect? No, but better than how it was being done.
Re:I do support this, in some ways. (Score:5, Insightful)
Say, for instance, your employer were able to collect you DNA. How is immaterial at the moment. Your company does this, and gets you profiled. Uh-oh, high risk for cancer. So they fire you so their insurance premiums won't go up. Also, can you imagine how much that information is worth to your insurance company?
Yes, there are already some laws on the books against genetic discrimination, but a lot of places don't have to tell you why they fired you, and if you didn't know they got the DNA...
Besides, it's just plain a privacy issue. My DNA is my business. Not yours. However, with the mail-in DNA testing, if you were to get some of my DNA, you could find out what's in my DNA. Why do you think you should have that right?
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Re:I do support this, in some ways. (Score:4, Insightful)
If you're a bad driver, should you not be charged more for liability insurance. If you've a genetic redisposition towards an expensive for of cancer, should you not pay more for the that? If you've have a genetic condition that carries the certainty of expensive treatment, then insurance isn't even relevent, you need a budget (or charity) not proection against risk.
Why people what to conflate health insurance and charity is beyond me - insurance companies are just about the worst possible choice as charity providers.
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Not just with genetic testing (Score:5, Informative)
Heck, in a few states (Cali included) we can't even send the client their report, we have to send it to the doctor's office.
I am pretty sure this law is in effect partially to protect the interests of the doctors in general.
I am trying to see the other side of this issue... (Score:3, Insightful)
Re:What's the alleged good reason... (Score:4, Insightful)
Because it would be very easy for me to collect saliva from someone whom I know in real life, and run tests on their DNA without their knowledge or consent. Also, there is a desire to prevent coersion towards that same goal.
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